Rapid SDH

K232436

iSchemaView, Inc. · cleared 2023-10-25 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Rapid SDH is a radiological computer-assisted triage and notification software device. The Rapid SDH module is an AI/ML module.”

Algorithmartificial intelligence algorithm (ML/AI/Neural Network)

source quote (p.7)

“Rapid SDH uses an artificial intelligence algorithm to analyze images and highlight cases with suspected hemispheric SDH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.10)

“Rapid has been designed to meet the cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.”

Validation studies (1)

Retrospective clinical

n=310 cases · 14 site(s)

endpoints: software's performance in identifying CT scans containing sub-dural intracranial hemorrhage (SDH); exceed 80% performance goal; median processing time to notify the clinician

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20, EN ISO 14971:2012, ISO 62304:2015

Reported performance (3 observations)

sensitivity0.924CI 0.871 – 0.956

source quote (p.10)

“Sensitivity (Se) was measured at Se: 0.924 (95% CI: 0.871 – 0.956)”

specificity0.987CI 95477 – 0.996

source quote (p.10)

“Sp: 0.987 (95% CI: 95477 – 0.996)”

aurocas written: “auc”0.995CI 0.986, 1.0

source quote (p.10)

“The RoC/AUC analysis using Rapid SDH Volume estimate as a predictor of Suspected SDH is AUC: 0.995 (0.986, 1.0)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K233512 (decision 2024-01-16) from iSchemaView, Inc. for a matching device line ("Rapid (6.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233512

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).